Resorbable and biocompatible fibre glass compositions and their uses

Abstract

Biocompatible and resorbable melt derived glass compositions which include: SiO 2 60-70 weight-%, Na 2 O 5-20 weight-%, CaO 5-25 weight-%, MgO 0-10 weight-%, P 2 O 5 0.5-3.0 weight-%, B 2 O 3 0-15 weight-%, Al 2 O 3 0-5 weight-%, and which contain less than 0.05 weight-% potassium. Biocompatible and resorbable glass fibers manufactured from these glass compositions, medical devices containing fibers of the invention, the use of these compositions for the manufacture of glass fiber and the use of the fibers for the manufacture of medical devices are also disclosed.

The invention claimed is: 
     
       1. An implant comprising a biocompatible and resorbable glass fibre manufactured from a biocompatible and resorbable melt derived glass composition comprising: 
       
         
           
                 
                 
                 
                 
               
                     
                 
                     
                   SiO 2   
                   60-70 
                   weight-%, 
                 
                     
                   Na 2 O 
                   5-20 
                   weight-%, 
                 
                     
                   CaO 
                   5-25 
                   weight-%, 
                 
                     
                   MgO 
                   0-10 
                   weight-%, 
                 
                     
                   P 2 O 5   
                   0.5-3.0 
                   weight-%, 
                 
                     
                   B 2 O 3   
                   0-15 
                   weight-%, 
                 
                     
                   Al 2 O 3   
                   0-5 
                   weight-% and 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
         comprising less than 0.05 weight-% potassium, said resorbable glass fiber having a full resorption time in vitro of 3-100 months when calculated using a resorption rate determined by dissolution in simulated body fluid under in sink conditions at +37° C. using a linear portion of a resorption curve. 
       
     
     
       2. The implant according to  claim 1 , wherein said glass fiber comprises chopped and/or continuous glass fibre. 
     
     
       3. The implant according to  claim 1  wherein said implant is selected from the group consisting of a joint implant, an internal/external fixation device, a stent, a pin, a nail, a screw, a spike, a stud, a plate, and a device for supporting tissue or bone healing and/or regeneration. 
     
     
       4. The implant according to  claim 1 , wherein the amount of biocompatible and resorbable glass fibre is >10 volume-% of the total volume of the fibers of said implant. 
     
     
       5. The implant according to  claim 1  wherein the fibers are embedded in a continuous polymer matrix. 
     
     
       6. The implant according to  claim 5  wherein the polymer matrix comprises at least one polymer selected from the group consisting of polyglycolide (PGA); copolymers of glycolide; polylactides (PLA); stereocopolymers of PLA; copolymers of PLA; terpolymers of PLA; polydepsipeptides; unsymmetrically 3,6-substituted poly-1,4-dioxane-2,5-diones; polyhydroxyalkanoates; PHB/b-hydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHPA); poly-p-dioxanone (PDS); poly-d-valerolactone; poly-ε-caprolactone; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU); polyvinyl-alcohol (PVA); polypeptides; poly-b-malic acid (PMLA); poly-b-alkanoic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides) and mixtures or thermosets thereof. 
     
     
       7. The implant according to  claim 1  wherein said melt derived glass composition comprises less than 0.03 weight-% potassium. 
     
     
       8. The implant according to  claim 1  wherein said melt derived glass composition comprises 
       
         
           
                 
                 
                 
                 
               
                     
                 
                     
                   SiO 2   
                   62-68 
                   weight-%, 
                 
                     
                   Na 2 O 
                   10-15 
                   weight-%, 
                 
                     
                   CaO 
                   8-20 
                   weight-%, 
                 
                     
                   MgO 
                   0-10 
                   weight-%, 
                 
                     
                   P 2 O 5   
                   0.5-3 
                   weight-%, 
                 
                     
                   B 2 O 3   
                   0-4 
                   weight-% and 
                 
                     
                   Al 2 O 3   
                   0-2.5 
                   weight-%. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
       9. The implant of  claim 1  wherein the thickness of the fibre is <300 μm. 
     
     
       10. The implant of  claim 1  wherein the tensile strength of the fibre is 0.7-3 GPa. 
     
     
       11. The implant according to  claim 6  wherein the stereocopolymers of PLA are selected from the group consisting of poly-L-lactide (PLLA), poly-DL-lactide (PDLLA) and L-lactide/DL-lactide copolymers. 
     
     
       12. The implant according to  claim 6  wherein the PLA copolymers are selected from the group consisting of lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d-valerolactone copolymers and lactide/ε-caprolactone copolymers. 
     
     
       13. The implant according to  claim 6  wherein the PLA terpolymers are selected from the group consisting of lactide/glycolide/trimethylene carbonate terpolymers, lactide/glycolide/ε-caprolactone terpolymers, and PLA/polyethylene oxide copolymers. 
     
     
       14. The implant according to  claim 1 , wherein said resorption time is 5-30 months.